UMIN-CTR Clinical Trial

Public title

Observational study of paclitaxel with Bevacizumab for advanced or recurrent breast cancer(SBCCSG-28)

Acronym

Observational study of paclitaxel with Bevacizumab for advanced or recurrent breast cancer(SBCCSG-28)

Scientific Title

Observational study of paclitaxel with Bevacizumab for advanced or recurrent breast cancer(SBCCSG-28)

Scientific Title:Acronym

Observational study of paclitaxel with Bevacizumab for advanced or recurrent breast cancer(SBCCSG-28)

Region

Japan

Condition

advanced or recurrent breast cancer

Classification by specialty

Hematology and clinical oncology

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the time to treatment failure and safty of Paclitaxel with Bevacizumab for advanced or recurrent breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

time to treatment failure

Key secondary outcomes

overall survival

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1.Treatment with Bevacizumab planned case
1-1.Histologically diagnosed with uniateral primary or recurrent breast cancer
1-2.>=20years old
1-3.No previous treatment with Bevacizumab
1-4.If hospital need written informed consent,is taken
2.In treatment with Bevacizumab case
2-1.Histologically diagnosed with uniateral primary or recurrent breast cancer
2-2.>=20years old
2-3.During treatment with Bevacizumab
2-4.If hospital need written informed consent,is taken
3.After treatment with Bevacizumab case
3-1.Histologically diagnosed with uniateral primary or recurrent breast cancer
3-2.>=20years old
3-3.Afer treatment with Bevacizumab
3-4.If hospital need written informed consent,is taken

Key exclusion criteria

Only treatment with Bevacizumab planned case
4-1.Have hypersensitivity to Bevacizumab
4-2.During pregnancy or lactation
4-3.Patients receiving anticoagulant therapy
4-4.Daily treatment with hight-dose aspirin(>=325mg/day) or non-steroidal anti-inflammatory medications for chronic inflammatory disease
4-5.Bleeding tendency(including significant hemoptysis or pulmonary tumor cavitation and necrosis),(INR>=1.5 within two weeks prior to entry)
4-6.Uncontrolled peptic ucer
4-7.Perforation of gastrointestional tract within one year
4-8.Renal failure to treated,2+ or higher proteinuria within two weeks prior to entry
4-9.Uncontrolled hypertension
4-10.Clinically significant cardiovascular disease(>=Grade2 according to the Common Toxicity Criteria of the National Cancer Institute,version 4), clinically important echocardiographic findigs,or past or current history(within the last one year)of myocardial infarction
4-11.Not appropriate for the study at the physician's assessment

Target sample size

70

Name of lead principal investigator

1st name
Middle name
Last name	Inoue Kenichi

Organization

Saitama Cancer Center

Division name

Breast Cancer Oncology

Zip code

Address

818 Komuro Ina-machi Kitaadachi-gun Saitama 362-0806

TEL

048-722-1111

Email

ino@cancer-c.pref.saitama.jp

Name of contact person

1st name
Middle name
Last name	Toshihiro Kai

Organization

Saitama Breast Cancer Clinical Study Group (SBCCSG)

Division name

Secretariat Division (Shintoshin Ladies' MammoClinic)

Zip code

Address

3F Capital building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan

TEL

048-600-1722

Homepage URL

http://www.sbccsg.org/

Email

toshikai@sbccsg.org

Institute

Saitama Breast Cancer Clinical Study Group (SBCCSG)

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

埼玉県立がんセンター（埼玉県），さいたま赤十字病院（埼玉県），埼玉社会保険病院（埼玉県），埼玉医大総合医療センター（埼玉県），自治医大さいたま医療センター（埼玉県）赤心堂病院（埼玉県），三井病院（埼玉県）

Date of disclosure of the study information

2012

Year

10

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Enrolling by invitation

Date of protocol fixation

2012

Year

09

Month

30

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

12

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

To evaluate the time to treatment failure and safty of Paclitaxel with Bevacizumab for advanced or recurrent breast cancer

Registered date

2012

Year

10

Month

11

Day

Last modified on

2017

Year

11

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010665